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NCT ID: NCT05740306 Enrolling by invitation - Clinical trials for Irritable Bowel Syndrome

Irritable Bowel Syndrome Overlaping Celiac Disease

IBSonCD
Start date: January 22, 2023
Phase:
Study type: Observational

The goal of this prospective observational cohort stuty is to assess the prevalence of overlap irritable bowel syndrome on coeliac disease in patients on gluten-free diet. The main questions it aims to answer are: - percentage of the occurrence of irritable bowel syndrome in the population of Polish patients with celiac disease on restrictive gluten-free diet - what is the correlation between the persistence of intestinal symptoms and adherence to a gluten-free diet (according to the patient's assessment) or confirmation of disease remission (based on histopathology or antibody level).

NCT ID: NCT05683795 Enrolling by invitation - Rectal Cancer Clinical Trials

PelvEx - Beating the Empty Pelvis Syndrome

Start date: January 3, 2023
Phase:
Study type: Observational

The empty pelvis syndrome is an unsolved and poorly defined problem severely affecting patients that have pelvic exenteration surgery, and also the teams looking after them. It is unclear what the anatomical and pathophysiological causes of the empty pelvis syndrome are, how it can be prevented, and how its sequelae can be measured. The evidence to guide decisions around the empty pelvis syndrome is of low quality, and so there is a large amount of variation in approaches between different hospitals. This consensus study will define a core outcome set for the empty pelvis syndrome, and establish current levels of consensus on pathophysiology and mitigation of the empty pelvis syndrome through a modified-Delphi process involving both healthcare professionals and patient representatives.

NCT ID: NCT05648851 Enrolling by invitation - Clinical trials for Sanfilippo Syndrome Type D

A Natural History Study of Sanfilippo Syndrome Type D

MPSIIID
Start date: January 22, 2023
Phase:
Study type: Observational

Sanfilippo syndrome type D is a ultra rare syndrome with limited available natural history data. This study is planned to document, through retrospective and prospective data collection, syndrome progression in children and young adults with Sanfilippo syndrome type D. The results from this study may inform future clinical studies in targeted therapies for patients with Sanfilippo syndrome type D and may serve as an external control since there are very few patients with Sanfilippo syndrome type D.

NCT ID: NCT05635747 Enrolling by invitation - Clinical trials for Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Start date: September 29, 2022
Phase:
Study type: Observational

Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel function. We propose to predigest the fat using a small cartridge attached to the feeding tube to allow for rapid absorption with the possibility of reducing or eliminating the need for intravenous nutrition. Goal of the observational study is to determine safety and tolerability of Relizorb Enzyme Cartridge for an additional 90 days after the original trial

NCT ID: NCT05629858 Enrolling by invitation - Obesity Clinical Trials

Time Restricted Eating for the Treatment of PCOS

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS. Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity. Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).

NCT ID: NCT05605886 Enrolling by invitation - Botulinum Toxin Clinical Trials

Botulinum Toxin A in Patients With Myofascial Pain Syndrome With and Without Zinc Supplementation

Start date: May 20, 2022
Phase: Early Phase 1
Study type: Interventional

Research question: Dose the use of oral zinc supplement improve the effects of botulinum toxins injection in patients with myofascial pain dysfunction syndrome? Statement of the problem: MPDS Patients treated with botulinum toxin A injection usually suffers from return of the symptoms which requires successive injections almost every (3-4M) Rationale for conducting the research: The concept of adding the zinc supplementation prior to BTXA injection is contributed to the fact that botulinum toxin is a zinc-dependent metalloprotease; therefore, every botulinum toxin molecule must be accompanied with a zinc molecule to effectively paralyze a muscle. However, commercially available BTXA preparations exclude zinc from their preparations, and BTX clinical efficiency and duration varies according to the zinc levels of the patient. Although the BTX effect could remain for several months, its zinc-dependent proteolytic activity befalls within hours of administration before the toxins are degraded in the tissues. Therefore, for achieving better results from BTX, the recipients should have adequate zinc levels at the time of administration. Therefore, oral zinc supplement intake prior to BTXA injection may enhance its clinical efficiency and duration. botulinum neurotoxins are the most potent toxins known. They bind to nerve cells, penetrate the cytosol and block neurotransmitter release. Comparison of their predicted amino acid sequences reveals a highly conserved segment that contains the HExxH zinc binding motif of metalloendo peptidases. The metal content of tetanus toxin was then measured and it was found that one atom of zinc is bound to the light chain of tetanus toxin. Zinc could be reversibly removed by incubation with heavy metal chelators. Zn2+ is coordinated by two histidines with no involvement in cysteines, suggesting that it plays a catalytic rather than a structural role. Bound Zn + was found to be essential for the tetanus toxin inhibition of neurotransmitter release in Aplysia neurons injected with the light chain. The intracellular activity of the toxin was blocked by phosphoramidon, a very specific inhibitor of zinc endopeptidases. Purified preparations of light chain showed a highly specific proteolytic activity against synaptobrevin, an integral membrane protein of small synaptic vesicles. The present findings indicate that tetanus toxin, and possibly also the botulinum neurotoxins, are metalloproteases and that they block neurotransmitter release via this protease activity. So The use of zinc supplementation prior to BTXA injection has been suggested by several previous studies to prolong its duration of action as well as improve its efficacy

NCT ID: NCT05583305 Enrolling by invitation - Stenosis Clinical Trials

Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome

ICAS_APS
Start date: October 12, 2022
Phase:
Study type: Observational

Antiphospholipid syndrome (APS) is an important cause of young stroke which could result in major disability. Cohort studies suggested that 17% of young ischemic stroke were accountable by APS (1). Although warfarin has been the mainstay of treatment in APS for the past decades, recurrent thromboembolism occurred up to 10% of warfarinized patients with APS (2, 3). These observations call for an in-depth understanding of disease mechanisms secondary to antiphospholipid antibodies (aPL). Contrary to traditional understanding, recent evidence suggested mechanisms of cerebrovascular ischemia in APS are far more complex than hypercoagulability alone. In the proposed cross-sectional study, we aim to determine the prevalence of intracranial stenosis, and to explore the correlations between the neuroimaging findings and the immunological as well as clinical features in patients with APS. In the proposed cross-sectional study, we aim to determine the prevalence of intracranial stenosis, and to explore the correlations between the neuroimaging findings and the immunological as well as clinical features in patients with APS.

NCT ID: NCT05578963 Enrolling by invitation - Clinical trials for Carpal Tunnel Syndrome

Correlation Between Palmaris Longus Muscle and Carpel Tunnel Syndrome

Start date: October 15, 2022
Phase:
Study type: Observational

The Palmaris longus (PL) muscle is a long, adaptable muscle that lies between the Flexor Carpi Ulnaris and Flexor Carpi Radialis muscles in the shallow volar segment of the lower arm. It has been acknowledged as a minimal muscle, nonetheless, in light of the fact that reviews have uncovered that around 30% of the populace might be feeling the loss of this muscle in one lower arm (one-sided) or the two lower arms (reciprocal), but the rate could continuously fluctuate. Carpal tunnel syndrome is an often-observed disease that causes pain, numbness, and tingling in the hand and arm. The disease occurs when one of the major nerves to the hand - the median nerve - is compressed as it moves across the wrist. The abnormal passage of palmaris longus tendon through the carpal tunnel leads to a contributory factor for causing the median nerve compression.

NCT ID: NCT05573542 Enrolling by invitation - Parkinson Disease Clinical Trials

Early Signs of Parkinsons Disease in IBS

Start date: May 1, 2023
Phase:
Study type: Observational

Bowel symptoms like constipation and abdominal pain are characteristic symptoms of irritable bowel syndrome (IBS). The pathogenesis and pathophysiology are not fully understood but subject to intense research, with emphasis on aberrations in the gut-brain axis, low-grade inflammation and gut barrier dysfunction that results in increased permeability and microbial translocation. Many patients with Parkinson's disease (PD) have reported bowel symptoms similar to that in IBS patients decades prior to the diagnosis of PD. Epidemiological studies show a significantly elevated risk of developing PD in IBS patients, though there is no knowledge on a pathogenic connection between these disorders. Recent studies show increased gut permeability and intestinal presence of pathological alpha-synuclein aggregates, the neuropathological hallmark in PD, indicating the involvement of the gut-brain axis. We aim to compare the presence of colonic alpha-synuclein between IBS, PD patients and healthy controls to relate these findings to intestinal permeability, ultrastructural mucosal changes, immune cell interactions, microbiota composition and brain function. This project could identify IBS groups at risk of developing PD and birth the development of early clinical diagnostic methods.

NCT ID: NCT05570864 Enrolling by invitation - Clinical trials for Acute Coronary Syndrome

Score TO Predict SHOCK - STOP SHOCK

Start date: October 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this international multicenter study is to develop a scoring system to identify the risk of developing cardiogenic shock (CS) in patients suffering from acute coronary syndrome (ACS) utilising artificial intelligence. Study hypothesis: A complex machine learning (ML) model utilising standard patient's admission data predicts the development of cardiogenic shock in patients suffering from acute myocardial infarction better than standard prediction models. Study objectives: The primary objective of this study is to further improve predictive parameters of #STOPSHOCK model for prediction of development of cardiogenic shock in patients suffering from acute myocardial infarction. The secondary objective of this study is to develop a new predictive model for the development of cardiogenic shock in patients suffering from acute myocardial infarction based on larger combined cohort of patients utilising advanced ML algorithms, continuous model performance monitoring and continual learning.